Active — Not RecruitingNot Applicable

Impact of the Helfer Skin Tap Technique on Pain and Comfort Levels During Ventrogluteal Injection: A Randomized Controlled Trial

Turkey (Türkiye)60 participantsStarted 2026-01-20

Plain-language summary

This randomized controlled study evaluates the effect of the Helfer Skin Tap Technique on pain and comfort during ventrogluteal intramuscular injections in adults. Participants aged 18-65 receiving diclofenac sodium injections at the Emergency Department of Yalova Training and Research Hospital will be randomly assigned to the intervention group (Helfer technique) or control group (standard injection). Pain and comfort will be measured using visual analog scales (VAS) before and after the injection. The study aims to provide evidence for improving injection pain management and patient comfort. Participation is voluntary, and all procedures follow ethical guidelines.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Individuals who can speak and understand Turkish, Individuals who are willing to participate in the study and have provided written informed consent, Aged between 18 and 65 years, Body Mass Index (BMI) between 18-24 kg/m², Individuals without sensory-motor deficits, diabetes, peripheral vascular disease, or neuropathy, Individuals who have not received oral or parenteral analgesic treatment before the injection, Individuals without ecchymosis, redness, or swelling at the injection site, Individuals without orthopedic issues preventing internal rotation of extremities, Individuals with intact orientation to time and place, Individuals without visual or hearing impairments. Exclusion Criteria: Individuals who refuse to undergo the technique applied within the study after being enrolled, Individuals who voluntarily withdraw from the study, Individuals for whom less than 24 hours have passed since their last injecti \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS) Score for Pain

Timeframe: Immediately (0 minute) and 5 minutes after the intramuscular injection.

Trial details

NCT IDNCT07583472

SponsorSeyda Can

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

View on ClinicalTrials.gov More PAIN, ANXIETY, AND COMFORT trials